Effect of Moderate Alcohol Consumption on Postprandial Mood

October 17, 2012 updated by: Henk FJ Hendriks, TNO

The Effect of Moderate Alcohol Consumption With a Meal in Different Ambiances on Postprandial Mood, Evaluated by Subjective and Physiological Responses

Rationale: Food choice is influenced by postprandial mood; the feelings of well-being after a meal. Postprandial mood can be measured by subjective responses. Physiological responses may play an important role in the generation of postprandial mood. However, the relationship between subjective and physiological responses after a meal is not clear yet. To investigate this relationship, moderate alcohol consumption will be used as a mood modulator, because of its well-studied effects on mood. Postprandial mood depends on the current mood state. Therefore the investigators will manipulate the current mood state by changing the ambiance to measure the influence of moderate alcohol consumption with a meal on postprandial mood in a pleasant or unpleasant ambiance.

Objective: To determine whether moderate alcohol consumption with a meal in different ambiances affects postprandial mood, evaluated by subjective and physiological parameters.

Study design: Randomized, placebo-controlled, single-blind, cross-over trial

Study population: 28 apparently healthy, normal weight (BMI 18.5-27 kg/m2) women (18-45 y), taking oral contraceptives.

Intervention: 4 times having dinner at TNO Zeist with either 3 glasses of sparkling white wine (~30g alcohol) or alcohol-free sparkling white wine in either a pleasant or unpleasant meal ambiance.

Hypothesis: It is hypothesized that moderate alcohol consumption with a meal in different ambiances changes the response of subjective and physiological parameters of mood.

  • Ho: there is no effect of alcohol consumption and ambiance on mood
  • H1: there is an effect of alcohol consumption and ambiance on mood

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

28

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
    • Utrecht
      • Zeist, Utrecht, Netherlands, 3704
        • TNO

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Healthy as assessed by the health and lifestyle questionnaire, (P9334 F02; in Dutch)
  • Females aged 18-45 years at Day 01 of the study
  • Taking a monophasic combined oral contraceptive pill at Day 01 of the study, with 21 days of taking pills with active ingredients followed by 7 days taking no pills or continuous intake of the oral contraceptive pill
  • Body Mass Index (BMI) of 18.5-27 kg/m2
  • Body weight between 57 and 80 kg
  • Normal Dutch eating habits as assessed by P9334 F02
  • Alcohol consumption ≥ 3 and ≤ 21 standard units/week
  • Voluntary participation
  • Having given written informed consent
  • Willing to comply with the study procedures, including refrain from alcohol 24 h before the test days and refrain from caffeine during the afternoon of the test day
  • Appropriate veins for blood sampling/cannula insertion according to TNO
  • Willing to accept use of all nameless data, including publication, and the confidential use and storage of all data for at least 15 years
  • Willing to accept the disclosure of the financial benefit of participation in the study to the authorities concerned

Exclusion Criteria:

  • Participation in any clinical trial including blood sampling and/or administration of substances up to 90 days before Day 01 of this study.
  • Having a history of medical or surgical events or disease that may significantly affect the study outcome, particularly physiological disorders, or psychiatric, metabolic or endocrine disease and gastrointestinal disorders.
  • Use of medication that may affect the outcome of the study parameters (e.g. antidepressive drugs).
  • Having a family history of alcoholism
  • Having a history of alcohol or drug related problems
  • Smoking
  • Reported unexplained weight loss or gain of > 2 kg in the month prior to the pre-study screening
  • Reported slimming or medically prescribed diet
  • Reported vegan, vegetarian or macrobiotic
  • Recent blood donation (<1 month prior to the start of the study)
  • Not willing to give up blood donation during the study.
  • Pregnant (to their own knowledge) or lactating or wishing to become pregnant in the period of the study
  • Personnel of TNO Zeist, their partner and their first and second degree relatives
  • Not having a general practitioner
  • Not willing to accept information-transfer concerning participation in the study, or information regarding her health, like laboratory results, findings at anamnesis or physical examination and eventual adverse events to and from his general practitioner.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Alcohol
  1. 3 glasses of sparkling white wine (30g alcohol) with dinner
  2. 3 glasses of alcohol free sparkling white wine (<2g alcohol) with dinner
Other: Nutrition
Moderate alcohol consumption with dinner (3 glasses of sparkling white wine, containing ca. 30 g alcohol)
Other Names:
  • Ethanol
  • Alcohol
  • Wine
Experimental: Ambiance
  1. Pleasant ambiance
  2. Unpleasant ambiance
Behavioral: mood manipulation
Mood will be manipulated by changing the ambiance in either a pleasant or unpleasant way.
Other Names:
  • Ambience
  • Ambiance
  • Positive affect
  • Emotion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Profile of mood states (POMS)
Time Frame: 5 times during study day, 4 study days (total 20x)
Difference between the change in the score of the 6 items of the POMS (after consumption of either white wine or alcohol free white wine with a meal in either a positive or negative ambiance. POMS will be measured before consumption, and 30min, 60min, 90min and 150min after consumption.
5 times during study day, 4 study days (total 20x)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

TNO

Investigators

  • Principal Investigator: Henk Hendriks, PhD, TNO

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2011

Primary Completion (Actual)

December 1, 2011

Study Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

August 26, 2011

First Submitted That Met QC Criteria

August 29, 2011

First Posted (Estimate)

August 30, 2011

Study Record Updates

Last Update Posted (Estimate)

October 18, 2012

Last Update Submitted That Met QC Criteria

October 17, 2012

Last Verified

October 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P9334

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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